FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 10449077
·
Received August 25, 2020
Report
- Report Number
- 3006630150-2020-03632
- Event Type
- Injury
- Date Received
- August 25, 2020
- Date of Event
- July 9, 2020
- Report Date
- August 25, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767749
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: LINEAR ST LEAD KIT 70 CM, UPN: (B)(4), MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7072721.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED PAIN TO THE RIGHT CERVICAL SPINE AND OCCIPITAL AREA FOLLOWING A CERVICAL SCS IMPLANT. XRAY REVEALED THAT LEADS HAD SLIPPED INTO GUTTER OF THE EPIDURAL SPACE. THE PATIENTS LEADS WERE REPLACED AND DISPOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 913118 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-70 | 7072561 | 08714729767749 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |